Program Planning
Averion provides full evaluation of its clients product development strategies; inclusive of screening new product concepts, evaluating pre-clinical and clinical data, determining product need, identifying regulatory hurdles, and researching current competition on the market. In addition, Averion will evaluate your pre-clinical and clinical data to predict the probability of Phase II and Phase III success.
Averion recommends sequences of Phase I-II-III clinical trial designs in recognition of the critical information that is needed to proceed most efficiently to product approval. This is done based on our experiences with the FDA/EMEA guidelines as well as historical paths to approval.
Clinical Trial Design
Clinical trial design begins with research on the clinical setting of the product: therapeutic principles, regulatory guidance documents including product history, background literature, competing product labeling and summary bases for approval, timelines and resources. Close collaboration with the Compliance, Medical, Clinical, and Biostatistics experts leads to defined project plans for monitoring, safety reporting, data management, analyses, and quality assurance. Responsibilities for the design can be shared with the Sponsor.
Averion can plan and design the entire device, drug or biologic trial or program. Our experience spans all therapeutic indications.
Clinical Trial Design Activities Include:
- Option Assessment Design
- Defining the Study Hypothesis
- Protocol Writing
- Case Report Form(s) Design (CRF Design)
- Investigator Meeting Planning
- Sample Size Justification
- Interim Analysis Plan Writing
- Analysis Planning
- Regulatory Guidance, Planning and Insight